CARE-CP (Testing a Cardiovascular Ambulatory Rapid Evaluation for Patients With Chest Pain) (CARE-CP)

CARE-CP (Testing a Cardiovascular Ambulatory Rapid Evaluation for Patients With Chest Pain )

The goal of this study is to determine if rapid outpatient evaluation vs hospitalization management is the best strategy (based on patient-centered measures and safe, equitable, and efficient resource use) for evaluating patients with acute chest pain who are at moderate risk for acute coronary syndrome (ACS). Patients will be randomized in the Emergency Department to either an outpatient evaluation (CARE-CP) or hospitalization evaluation for their symptoms.

Study Overview

• Status: Recruiting
• Conditions: Chest Pain
• Intervention / Treatment: Behavioral: Outpatient Evaluation; Behavioral: Hospitalization Evaluation

Detailed Description

Current care patterns for the 7 million patients visiting Emergency Departments (EDs) in the United States with chest pain are heterogeneous and not sustainable from a healthcare quality or economic perspective. Chest pain is the second most common cause of ED visits and the most common reason for short-stay hospitalizations. During these hospitalizations patients undergo in-depth evaluations (stress testing, computed tomography coronary angiography, or invasive angiography), but ultimately <10% are diagnosed with acute coronary syndrome (ACS). These evaluations cost $3 billion annually and strain health system resources without clear evidence of improved health outcomes or patient experience. The preliminary data suggest that moderate risk patients (35% of patients with chest pain) can be safely managed as outpatients using a cardiovascular ambulatory rapid evaluation (CARE-CP) strategy as an alternative to hospitalization. In the CARE-CP strategy, patients are discharged from the ED and receive outpatient clinic follow-up within 72 hours focused on medical management for cardiovascular risk factors (e.g., hypertension, diabetes) and determining whether further cardiac testing is needed. This strategy aims to enhance patient-centered outcomes while safely and equitably decreasing hospital resource utilization. However, equipoise exists between outpatient and hospitalization strategies for moderate risk patients. There is a paucity of prospective data evaluating the efficacy and patient-centeredness of outpatient chest pain evaluation strategies in moderate risk patients. Thus, it is unclear whether use of an outpatient chest pain management strategy (CARE-CP) will safely reduce healthcare utilization and be preferred by patients compared to a traditional hospitalization strategy. To address this key evidence gap, the study proposes the first prospective multisite randomized trial testing outpatient vs hospitalization strategies in moderate risk patients. The research teams will randomize 502 patients 1:1 to the CARE-CP or hospitalization management arms at three ED sites with a history of high recruitment rates and productive collaborations in cardiovascular clinical trials. The primary outcome will be hospital-free days (HFD) over a 30-day period. This novel trial addresses a key evidence gap by providing guidance on how best to evaluate moderate risk ED patients with acute chest pain. Without this guidance care patterns are likely to remain heterogeneous, inefficient, non-patient-centered, and unguided by the highest level of evidence. We hypothesize that data from this trial will support widespread implementation of a CARE-CP strategy, which could improve the quality and value of care for millions of patients in the U.S. and beyond.

• Study Type: Interventional
• Enrollment (Estimated): 502
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Lauren Koehler; Phone Number: 336-716-4646; Email: lekoehle@wakehealth.edu
• Study Contact Backup: Name: Lauren Victory; Phone Number: 336-716-7260; Email: lvictory@wakehealth.edu

Study Locations

• United States
  • Michigan
    • Detroit, Michigan, United States, 48202
      • Recruiting
      • Henry Ford Hospital
  • North Carolina
    • Charlotte, North Carolina, United States, 28203
      • Recruiting
      • Carolinas Medical Center
    • Winston-Salem, North Carolina, United States, 27157
      • Recruiting
      • Wake Forest University Health Sciences
      • Contact: Lauren Koehler

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Age ≥21 years old
• Chest pain or Symptoms of acute coronary syndrome (ACS)
• Moderate risk of ACS (all of the below)
• Hear Score 4-6
• Non-Ischemic electrocardiogram (ECG)

• Two Troponin measures < Sex-Specific Upper Reference Limit

  • Women <15 pg/ml
  • Men <20 pg/ml

• No prior coronary artery disease (CAD)

  • No Prior Myocardial Infarction (MI)
  • No Prior Coronary Revascularization Procedures
  • No Patients with ≥ 70% Obstructive Coronary Disease

Exclusion Criteria:

• ST Elevation Myocardial Infarction (STEMI) Activation
• ST Changes or new T-wave inversions ≥1mm on ECG
• Any Elevated Troponin Measure (Based on Sex-Specific 99th Percentile)
• Serial change between Troponin Measures (Delta) ≥5 pg/mL
• Stress Echocardiography, Nuclear Stress Test, Stress ECG, Stress Cardiac MRI, Coronary CT Angiogram (CCTA), Invasive Coronary Angiography (Cardiac Cath) within 1 year
• "Clean" CCTA or Cardiac Cath (0% stenosis in all vessels) within the past 2 years
• Chest Trauma
• Pregnancy
• Life Expectancy < 1 year
• Other comorbid conditions requiring hospitalization
• Unstable Vitals (Blood Pressure <90, Heart Rate >120 or <50, O2 Sat <90%)
• End Stage Renal Disease; Dialysis or estimated glomerular filtration rate (eGFR) <30 mL/min
• Transfers From Another Hospital
• Non-English Speaking
• Prisoners
• Prior Enrollment
• Already Enrolled in Other Interventional Trial

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Outpatient Evaluation; Patients randomized to this arm are discharged and receive outpatient evaluation, or cardiovascular ambulatory rapid evaluation (CARE), focused on medical management for cardiovascular risk factors (e.g. hypertension) within 72 hours of Emergency Department discharge.	Behavioral: Outpatient Evaluation; Subjects will receive an outpatient evaluation within 72 of being discharged from the ED.; Other Names: CARE-CP (Cardiovascular Ambulatory Rapid Evaluation)
Other: Hospitalization Evaluation; Patients randomized to this arm receive evaluation for their symptoms in a hospital ward, observation unit, or emergency department boarding.	Behavioral: Hospitalization Evaluation; Patients randomized to this arm receive evaluation for their symptoms in a hospital ward, observation unit, or emergency department boarding.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hospital-free days (HFD) at 30-days post-randomization	Time spent in a hospital setting at 30 days post-randomization will be measured and subtracted from time spent outside the hospital. Hospital time is broadly defined, based on a patient-centered definition of cumulative time spent in the ED, observation unit, or hospital ward. Consistent with prior trials, patients who experience death during the follow-up period are assigned zero HFDs.	Day 30

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hospital-free days (HFD) at 1-year post-randomization	Time spent in a hospital setting at 1 year post-randomization will be measured and subtracted from time spent outside the hospital. Hospital time is broadly defined, based on a patient-centered definition of cumulative time spent in the ED, observation unit, or hospital ward. Consistent with prior trials, patients who experience death during the follow-up period are assigned zero HFDs.	Year 1
Cardiovascular Hospital-free days (HFD) at 30-days post-randomization	Rates of cardiovascular rehospitalizations at 30-days post-randomization will be analyzed between the two treatment arms.	Day 30
Cardiovascular Hospital-free days (HFD) at 1 year post-randomization	Rates of cardiovascular rehospitalizations at 1 year post-randomization will be analyzed between the two treatment arms.	Year 1
Rate of noninvasive cardiac testing at 30-days post-randomization	The rates of noninvasive testing (stress testing and coronary computed tomography angiography), at 30-days post-randomization will be analyzed between the two treatment arms.	Day 30
Rate of noninvasive cardiac testing at 1 year post-randomization	The rates of noninvasive testing (stress testing and coronary computed tomography angiography), at 1 year post-randomization will be analyzed between the two treatment arms.	Year 1
Rate of invasive cardiac testing at 30-days post-randomization	The rates of invasive testing (coronary angiography), at 30-days post-randomization will be analyzed between the two treatment arms.	Day 30
Rate of invasive cardiac testing at 1 year post-randomization	The rates of invasive testing (coronary angiography), at 1 year post-randomization will be analyzed between the two treatment arms.	Year 1
Cardiovascular repeat ED visits at 30-days post-randomization	The rates of Cardiovascular repeat ED visits at 30-days post-randomization will be analyzed between the two treatment arms.The ED visit will be categorized as cardiovascular if a cardiac procedure is performed, the primary reason for admission is possible ACS, or a discharge diagnosis relates to chest pain, MI, ACS, heart failure, or other cardiac disease (e.g., dysrhythmia, pericardial disease, etc.). Cardiac procedures include stress testing, noninvasive and invasive coronary angiography, coronary revascularization, and pacemaker or defibrillator insertion.	Day 30
Cardiovascular repeat ED visits at 1 year post-randomization	The rates of Cardiovascular repeat ED visits at 1 year post-randomization will be analyzed between the two treatment arms.The ED visit will be categorized as cardiovascular if a cardiac procedure is performed, the primary reason for admission is possible ACS, or a discharge diagnosis relates to chest pain, MI, ACS, heart failure, or other cardiac disease (e.g., dysrhythmia, pericardial disease, etc.). Cardiac procedures include stress testing, noninvasive and invasive coronary angiography, coronary revascularization, and pacemaker or defibrillator insertion.	Year 1
Cardiovascular rehospitalizations at 30-days post-randomization	The rates of Cardiovascular rehospitalizations at 30-days post-randomization will be analyzed between the two treatment arms.The rehospitalization will be categorized as cardiovascular if a cardiac procedure is performed, the primary reason for admission is possible ACS, or a discharge diagnosis relates to chest pain, MI, ACS, heart failure, or other cardiac disease (e.g., dysrhythmia, pericardial disease, etc.). Cardiac procedures include stress testing, noninvasive and invasive coronary angiography, coronary revascularization, and pacemaker or defibrillator insertion.	Day 30
Cardiovascular rehospitalizations at 1 year post-randomization	The rates of Cardiovascular rehospitalizations at 1 year post-randomization will be analyzed between the two treatment arms.The rehospitalization will be categorized as cardiovascular if a cardiac procedure is performed, the primary reason for admission is possible ACS, or a discharge diagnosis relates to chest pain, MI, ACS, heart failure, or other cardiac disease (e.g., dysrhythmia, pericardial disease, etc.). Cardiac procedures include stress testing, noninvasive and invasive coronary angiography, coronary revascularization, and pacemaker or defibrillator insertion.	Year 1
Patient satisfaction (SAPS questionnaire)	Satisfaction will be assessed using the Short Assessment of Patient Satisfaction (SAPS). A patient satisfaction survey will be sent that evaluates clinician communication, participation in medical decision-making, respect by the clinician, clinician carefulness, time with the clinician, and treatment effect, in any service setting on a five-point Likert scale from "very dissatisfied" to "very satisfied". Scores from each item are summed and range from 0 (extremely dissatisfied) to 28 (extremely satisfied).	Day 30
Patient experience (GS-PEQ instrument)	Experience will be measured using the Generic Short Patient Experience Questionnaire (GS-PEQ). A patient experience survey will also be sent out to evaluate which assesses timeliness and organization of medical services, confidence in the clinician and treatment, patient involvement in decision-making, clinician communication, patient outcomes, and incorrect treatment on a 5-point Likert-scale from "not at all" to "to a very large extent" and one question (on wait times) scored on a 4-point Likert scale from "no" to "yes, way too long. A mean score can be calculated for each patient, with higher scores indicating better experience.	Day 30
Out-of-pocket cost (based on billing data)	Patient satisfaction, patient experience, and out-of-pocket costs will be measured in all trial participants. Financial records will be utilized from each site to determine patient billing, including the amount covered by insurance vs. patient responsibility. Each item will be measured in U.S. dollars and summed for total cost.	Day 30
Drivers of Patient Satisfaction and Experience (Qualitative)	A subset of 100 patients (50 from each arm) will be purposively selected to ensure diversity in sex, race, ethnicity, socioeconomic status (SES), and health literacy for 30-minute semi-structured phone interviews to determine key drivers of patient satisfaction and experience. We will use an explanatory sequential mixed-methods design, in which participants' quantitative data will guide the collection and analysis of their qualitative data.These data will provide key context and meaning to the patient's quantitative response regarding patient satisfaction, experience, and out-of-pocket cost.	Day 30

Collaborators and Investigators

• Sponsor: Wake Forest University Health Sciences
• Collaborators: Agency for Healthcare Research and Quality (AHRQ)
• Investigators: Principal Investigator: Simon Mahler, MD, MS, Wake Forest University Health Sciences

Study record dates

Study Major Dates

• Study Start (Actual): October 2, 2023
• Primary Completion (Estimated): October 1, 2025
• Study Completion (Estimated): October 1, 2026

Study Registration Dates

• First Submitted: June 1, 2023
• First Submitted That Met QC Criteria: June 1, 2023
• First Posted (Actual): June 9, 2023

Study Record Updates

• Last Update Posted (Actual): December 15, 2023
• Last Update Submitted That Met QC Criteria: December 14, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: Cardiovascular Diseases; Acute Coronary Syndrome
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Chest Pain
• Other Study ID Numbers: IRB00092604

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No